With so many promising digital therapeutics for anxiety and obsessive-compulsive (OC) spectrum problems, there is an urgent need to consider how evolving regulatory oversight of digital therapeutics is poised to shift how these tools are developed, evaluated, reimbursed, and delivered. In this commentary, we discuss both opportunities and potential pitfalls associated with emerging government regulations of digital therapeutics for mental health, and we consider how applying the traditional ‘prescription-based’ medical approval paradigm to digital therapeutics for mental health could ultimately undermine and limit the broad accessibility of these software-based innovations that have been explicitly designed to expand the accessibility of care. For example, the vast majority of behavioural and mental health providers do not have ‘prescription privileges’ (a term originally rooted in pharmacologic practices), and as a result, under current regulations in the U.S. would not be authorized to make FDA-cleared digital therapeutics available to their patients. This is particularly concerning given that most digital therapeutics for mental health are directly rooted in psychological and behavioural science, yet psychologists would not be authorized to incorporate these innovations into their practice. We consider how synchronizing regulatory standards across countries may prove useful, and we conclude by arguing that multidisciplinary teams making regulatory decisions concerning digital therapeutics for mental health must include representation from the discipline and practice of psychology.

中文翻译：

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规范心理健康的数字疗法：机遇、挑战和心理学​​家的重要作用

有这么多有希望的焦虑和强迫症 (OC) 频谱问题的数字疗法，迫切需要考虑如何不断发展的数字疗法监管监督将如何改变这些工具的开发、评估、报销和交付方式。在本评论中，我们讨论了与新兴的政府对心理健康数字疗法的监管相关的机会和潜在陷阱，并考虑将传统的“基于处方”的医学批准范式应用于心理健康数字疗法最终会破坏和限制这些基于软件的创新的广泛可访问性，这些创新明确旨在扩大护理的可及性。例如，绝大多数行为和心理健康提供者没有“处方特权”（一个最初植根于药理学实践的术语），因此，根据美国现行法规，将无权向 FDA 批准的数字疗法提供他们的病人。鉴于大多数心理健康数字疗法直接植根于心理和行为科学，这一点尤其令人担忧，但心理学家无权将这些创新融入他们的实践中。我们考虑了跨国家同步监管标准如何被证明是有用的，我们最后认为，多学科团队做出有关心理健康数字治疗的监管决策必须包括心理学学科和实践的代表。